Effect of Camel Milk on Chronic Hepatitis C

NCT ID: NCT02216045

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .

Detailed Description

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The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.

Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peginterferon ,Ribavirin

drug :Peginterferon, Ribavirin,

Group Type ACTIVE_COMPARATOR

Peginterferon, Ribavirin

Intervention Type DRUG

Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.

Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.

Peginterferon, Ribavirin, camel milk

drug :Peginterferon, Ribavirin, camel milk

Group Type EXPERIMENTAL

Peginterferon, Ribavirin, camel milk

Intervention Type DRUG

Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.

Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .

camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

Interventions

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Peginterferon, Ribavirin, camel milk

Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.

Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .

camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

Intervention Type DRUG

Peginterferon, Ribavirin

Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.

Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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PEGASYS® COPEGUS®. Dromedary milk (camel milk ) PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)

Eligibility Criteria

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Inclusion Criteria

* HCV (hepatitis C virus ) RNA positive
* Age age groups (18 to 70 years)

Exclusion Criteria

* Ongoing pregnancy or breast feeding
* Hx of HCC(hepatocellular carcinoma )
* Hx of alcoholic liver disease
* Hx of bleeding from esophageal varices
* Hx of hemochromatosis
* Hx of autoimmune hepatitis
* Hx of Suicidal attempt
* Hx of cerebrovascular dis
* Hx of severe retinopathy
* Hx of severe psoriasis
* Hx of scleroderma
* Hx of metabolic liver disease
* Hx of SLE(systemic lupus erythematosus )
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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mohammadreza noras

Phd student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyyd Musa Al-Reza Hosseini, professor.As

Role: STUDY_CHAIR

Ghaem Gastrointestinal Clinic

Mehdi Yousefi, MD.Phd

Role: STUDY_DIRECTOR

Faculty of Traditional Medicine Clinic

Mohammadreza Noras, Phd student

Role: PRINCIPAL_INVESTIGATOR

Faculty of Traditional Medicine Clinic

Ali Taghipour, MD.Phd

Role: STUDY_DIRECTOR

MUMS Faculty of Health Sciences

Said Zibae, MD.Phd

Role: STUDY_DIRECTOR

Razi vaccine and serum Research Institue of Mashhd

Locations

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Faculty of Traditional Medicine

Mashhad, Razavi Khorasan Province, Iran

Site Status

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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Mashhad UMS

Identifier Type: -

Identifier Source: org_study_id

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